A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency

This study has been terminated.

(See termination reason in detailed description.)

Sponsor:

Pfizer

ClinicalTrials.gov Identifier:

NCT00314938

First Posted: April 17, 2006

Last Update Posted: May 16, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling

The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

6 Years to 12 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

1.Male and female children with a minimum age of 6 years

2. Prepubertal as defined by Tanner staging

3. Growth hormone deficiency

Exclusion Criteria:

1. PGHD patients with uncontrolled pituitary tumor growth

2. Tumors within 3 mm of the optic chiasm

3. Serum ALT and/or AST >= 1.5 times the upper limit of normal range

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314938